Botanical Review Team Develops “Post-CMC” Approach
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA’s Botanical Review Team has identified new ways to help assure the quality of complex natural mixtures. While not specified in the agency’s 2004 guidance on botanical drugs, the team is adding its “post-CMC” approach to conventional CMC analyses and “pre-CMC” agricultural oversight.
You may also be interested in...
Fulyzaq Review Shows FDA Adapting Smoothly To Adaptive Trial Design
Review documents show that Fulyzaq’s clear, if modest, treatment effect compared to placebo was buttressed by a series of exploratory subgroup analyses suggesting greater efficacy in sicker patients.
Keeping Track: Novel Orphan Drugs Amondys 45, Nulibry Clear US FDA; First-Line NSCLC Claim For Libtayo
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Keeping Track: Novartis Entresto Wins Expanded Heart Failure Claim; Padcev, Vicineum Seek Bladder Cancer Approvals
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: